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  • 125547Orig1s000 - Food and Drug Administration
    The popPK analysis supports the proposed 800 mg necitumumab on Days 1 and 8 of a 3-week cycle as an appropriate dosage regimen in the indicated NSCLC patient population
  • 125547Orig1s000 - Food and Drug Administration
    For those randomized to the necitumumab arm, necitumumab was administered at a dose 800 mg by intravenous infusion on days 1 and 8 of each cycle, prior to infusion of gemcitabine and cisplatin, and as a single agent following completion of chemotherapy disease progression or unacceptable toxicity
  • Population Pharmacokinetics of Necitumumab in Cancer Patients
    Nonlinear mixed-effects modeling of serum concentration data across five clinical studies (phases I–III) indicated that necitumumab exhibited target-mediated drug disposition, commonly observed with monoclonal antibodies, and that pharmacokinetics were expected to be linear in the studied dose ranges when administered as repeated infusions
  • Population Pharmacokinetics of Necitumumab in Cancer Patients - Springer
    Necitumumab effective half-life was estimated to approx-imately 2 weeks, and steady state was achieved within three to four cycles of treatment The phase III dosing schedule of 800 mg dosed on days 1 and 8 of a 21-day schedule resulted in serum concentrations that exceeded the 40-mg L threshold indicated by preclinical experiments
  • Exposure–Response Analysis of Necitumumab Efficacy in Squamous Non . . .
    Pharmacokinetic simulations predicted that 800 mg given on day 1 and day 8 of a 3‐week schedule would produce serum levels exceeding the preclinical threshold level in patients, where the schedule was selected to match the gemcitabine‐cisplatin chemotherapy backbone administration schedule
  • 125547Orig1s000 - Food and Drug Administration
    The recommended clinical dose of necitumumab is 800 mg administered as an intravenous infusion once daily on Days 1 and 8 of each 3-week cycle Nonclinical pharmacology, pharmacokinetic, and toxicology studies have been submitted to support the approval of necitumumab for the proposed indication
  • 125547Orig1s000 - Food and Drug Administration
    The SQUIRE study enrolled 1093 patients with metastatic NSCLC who were randomized (1:1) to receive either necitumumab 800 mg intravenously on days 1 and 8 in combination gemcitabine 1250 mg m2 on days 1 and 8 and cisplatin 75 mg m2 on day 1 of every 3-week cycle (N+GC) or gemcitabine and cisplatin (GC) alone
  • 125547Orig1s000 - Food and Drug Administration
    Necitumumab 800 mg intravenously on days 1 and 8, pemetrexed 500 mg m2 intravenously on day 1, and cisplatin 75 mg m2 intravenously on day 1 of each 21-day cycle
  • 125547Orig1s000 - Food and Drug Administration
    The dating period for PORTRAZZA shall be 24 months from the date of manufacture when stored at 2-8 °C The date of manufacture shall be defined as the date of final sterile filtration of the formulated drug product The dating period for necitumumab drug substance shall be (b) (4) months from the date of manufacture when stored at (b) (4) °C
  • Necitumumab - Archive. org
    Patients received necitumumab 800 mg by intravenous infusion on days 1 and 8, gemcitabine 1250 mg m 2 on days 1 and 8 plus cisplatin 75mg m 2 on day 1 of each 3-week cycle (N=545) or GC alone (N=548)





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